Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
VALPROIC ACID
PHARMEL INC
N03AG01
VALPROIC ACID
500MG
CAPSULE (ENTERIC-COATED)
VALPROIC ACID 500MG
ORAL
100/500
Prescription
MISCELLANEOUS ANTICONVULSANTS
Active ingredient group (AIG) number: 0112996003; AHFS:
CANCELLED POST MARKET
2016-10-25
PRODUCT MONOGRAPH PR PHL-VALPROIC ACID Valproic Acid Capsules, USP 250 mg PR PHL-VALPROIC ACID E.C. Valproic Acid Enteric Coated Capsules 500 mg PR PHL-VALPROIC ACID Valproic Acid Oral Solution, USP 250 mg/5 mL ANTIEPILEPTIC PHARMEL INC. DATE OF REVISION: 6111 Royalmount Avenue, suite 100 January 27, 2012 Montreal, Canada H4P 2T4 SUBMISSION CONTROL NO: 152317 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION....................................................... 3 INDICATIONS AND CLINICAL USE ............................................................................. 4 CONTRAINDICATIONS................................................................................................... 4 WARNINGS AND PRECAUTIONS ................................................................................. 5 ADVERSE REACTIONS ................................................................................................. 16 DRUG INTERACTIONS ................................................................................................. 20 DOSAGE AND ADMINISTRATION ............................................................................. 29 OVERDOSAGE................................................................................................................ 31 ACTION AND CLINICAL PHARMACOLOGY............................................................ 32 STORAGE AND STABILITY ......................................................................................... 35 DOSAGE FORMS, COMPOSITION AND PACKAGING............................................. 35 PART II: SCIENTIFIC INFORMATION ............................................................................. 36 PHARMACEUTICAL INFORMATION ......................................................................... 36 CLINICAL TRIALS ......................................................................................................... 37 DETAILED PHARMACOLOGY .................................................................................... 43 TOXICOLOGY.. Prečítajte si celý dokument